ArisGlobal - Samedan Ltd · high administrative burdens to manage paper-based study documentation. Investigator portals allow study sites to move from paper-based to electronic investigator

ArisGlobalWhite Paper

Investigator Portals: Facilitating and StreamliningCommunication & Collaborationwith Study Sites

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Page 2 ArisGlobalWhite Paper

EXECUTIVE OVERVIEW 4

LEVERAGING INVESTIGATOR PORTALS TO ADVANCE TRIAL OUTCOMES 5

INVESTIGATOR PORTALS: ADDRESSING FIVE KEY AREAS 6

IMPORTANT TECHNOLOGY AND DESIGN ASPECTS 11

SUMMARY 15

REFERENCES 15

ABOUT ARISGLOBAL 16

CONTENTS

Page 3Investigator Portals: Facilitating and Streamlining

Communication & Collaboration with Study Sites

Electronic data capture (EDC) was a quantum leap in the process of data capture and data

cleaning. In addition to speeding up the data management process, it is also the prerequisite for

new ways of conducting clinical trials, e.g., for adaptive trials. It is, however, important to realize

that EDC focusses only on a small portion of the clinical trial process. It is time to take the next

step and investigate how those interactions with sites that are not covered by EDC can be taken

from paper to electronic. This is the aim of investigator portals.

The reality is that investigator site personnel are often frustrated with the lack of transparency and

communication with their sponsors, leading to significant dissatisfaction and often withdrawal from

current and future studies. The adoption of investigator portals gives sponsors a platform that

fosters collaboration and improves site management.

Essentially, the adoption of investigator portals improves upon five areas:

• Investigator files. With speed to market in mind, the process of exchanging paper-based

documents is a waste of resources, time and money. Valuable time is lost during site initiation,

leading to delays in the start of patient enrollment. In addition, site and sponsor personnel face

high administrative burdens to manage paper-based study documentation. Investigator portals

allow study sites to move from paper-based to electronic investigator files.

• Feasibility questionnaires. Fast template-based creation of high-quality questionnaires,

electronic distribution with cover letters and other accompanying documents, management of

reminders and assessment support through automatic scoring of completed questionnaires are

examples of how investigator portals streamline this important activity, which can enable faster

and more efficient site selection.

• Safety reporting (SUSARs). Regulatory requirements demand that sponsors share

important new safety information, e.g., SUSARs, within strict timeframes with their investigators.

Electronic tools can reduce efforts and ensure compliance through automatic generation of

distribution lists and cover letters, save distributions using different media, and automatically track

acknowledgments.

• Training management. Investigator portals allow site personnel to take both general and

study-specific trainings online and to document their completion. Sponsors have full control and

a real-time overview of their investigators’ training progress.

• Investigator self-registration. Investigators worldwide can express their interest in

upcoming trials, expanding the investigator network of the sponsor or contract research

organization (CRO).

This white paper explores in more detail how investigator portals impact each of these five areas. It

will touch upon the technology, such as single sign-on, and portal design aspects that should be

considered when evaluating such a solution. ArisGlobal believes that investigator portals are an

important competitive advantage that sponsors should evaluate as they seek to increase collaboration,

expedite processes, improve quality and reduce the costs of administering TMF-related document

management.

It is time to take the next step and investigate

how those interactions with sites that are not

covered by EDC can be taken from paper to

electronic. This is the aim of investigator

portals.

EXECUTIVE OVERVIEW


A primary challenge of any clinical trial is finding, training and retaining investigative sites. As

regulations and study protocols increase in complexity, clinical research places an extraordinary

burden on investigators and their staff. Relationships become easily strained and many investigators

simply end up leaving clinical research altogether. Recent trends show a lack of experienced

investigators taking their place, with most new investigators now having very little research

experience. It is essential that these relationships are repaired and the burden of conducting a

clinical trial does not fall on the shoulders of the site staff.

Many sponsors are now looking to deploy site portals to improve site collaboration and facilitate

site start-up. A site portal offers unique opportunity to centralize contract/document exchange,

feasibility, training, and SAE notifications in a way never before possible. Fortunately, investigator

acceptance of technology, fuelled by the nearly total adoption of EDC, allows software vendors

such as ArisGlobal to design and deliver site portals that benefit both sponsors and investigators.

LEVERAGING INVESTIGATOR PORTALS TO ADVANCE TRIAL OUTCOMES



Figure 1 - 5 Key Areas: Specific site interactions deserving of electronic communication and collaboration

1. Investigator File

Regulatory requirements and adherence to Good Clinical Practice (GCP) guidelines1 for the

retention of clinical trial records make it an imperative that all essential documents of both the

sponsor and investigator sites are filed correctly and in a timely manner.

The management of the investigator file is a burden for site personnel as well as the sponsor

and/or CRO. Especially during trial setup huge amounts of documents need to be shared between

the sponsor / CRO and the site. In the DIA Trial Master File (TMF) reference model2,

approximately 40% of the TMF artifacts are classified as investigator documents. Many of these

documents are created by the sponsor and given to the site, including study manuals, study

protocols and amendments. Other documents need to be collected from the site, such as

protocol signature pages, CVs, etc. Almost all of these documents become part of the investigator

file.

Given this reality, the process of exchanging paper documents is a waste of resources, time and

money. Valuable time is lost during site initiation, leading to delays in the start of patient

enrollment. Documents need to be printed, filed into binders and shipped to the sites. Whenever

a new document is issued or a new version of the documents created, clinical research associates

(CRAs) need to spend valuable time during their site visit checking if these documents have made

their way into the site binders. Investigators find it difficult to store the binders given the limited

amount of space available in most sites. Usage of paper-based documents is limited and more

difficult, for example when searching for a specific topic (e.g., searching for what the protocol says

with respect to a specific trial procedure).

Investigator portals make lives much easier for site personnel and sponsors as they allow moving

from a paper-based to an electronic process. The need for a paper-based investigator file is limited

to those documents not shared with the sponsor, e.g., because they contain redacted identification

information about the patients such as signed informed consent forms. The vast remainder of

documents can be handled electronically and shared with the site as PDFs for archival purpose at

the end of a trial, similar to what is done with case report forms (CRFs) when using EDC.

As an organization evaluates possible solutions, ArisGlobal believes that a well-designed investigator

portal covers five key areas:

Whenever a new document is issued or a new

version of the documents created, clinical

research associates (CRAs) need to spend

valuable time during their site visit checking if

these documents have made their way into the

site binders.

INVESTIGATOR PORTALS: ADDRESSING FIVE KEY AREAS


The benefits of a secure, electronic management of documents are numerous. Just to mention a

few, site setup is accelerated considerably, leading to faster site initiation. The administrative efforts

for managing investigator files are reduced significantly. Some tasks related to investigator files can

be done remotely, allowing the CRA to spend his time during regular site visits on more value

adding task.

2. Feasibility Questionnaires

Clinical trials are now much more complex and site recruitment requirements are becoming

increasingly more stringent. In this environment, sponsors rely on feasibility questionnaires as a

valuable tool to aid in the recruitment, assessment and resource allocation process. Feasibility

questionnaires are used at the beginning of a study or when searching for new sites while the

study is ongoing. Their main purpose is to assess if a site might be suitable to participate in a

specific clinical trial before an expensive pre-study site visit is scheduled. Often feasibility

questionnaires are created from scratch or a copy from a previous study is taken as a starting point

in developing a new one. This is not efficient and casts some doubts on the quality of the

questionnaires.

ArisGlobal recommends that feasibility questionnaires be designed based on templates. This helps

sponsors adhere to company standards and speeds the design of the questionnaires. Similar to

EDC, individual questions preferably should be taken from a library, which ensures the questions

are well phrased so that the answers from the sites give them the desired information. Once

designed, questionnaires need to be distributed to sites with an accompanying cover letter and

additional documents such as a study synopsis.

ArisGlobal recommends that feasibility

questionnaires be designed based on templates.



Figure 2 – Feasibility Questionnaires: Leveraging an investigator portal, Sponsors can improve site selection and

retention strategies with online feasibility questionnaires.

Investigator portals can automate this development and deployment process, as well as support

the tracking of the responses and the management of reminders. Investigators have the ease of

completing the questionnaires online. If designed properly, investigator portals can support the

assessment with an automatic scoring of the answers given by the investigators and deliver a

ranking of potential investigators based on the total score. This can then be taken as a starting

point for decision making and scheduling pre-study site visits to be conducted by the CRAs.

3. Safety Reporting

For many biopharmaceutical companies, the distribution of safety reports to investigators and

IRBs/IECs is fraught with challenges. The manual, paper-based effort to send and track the required

safety reports within regulatory timelines can turn into a costly and labor-intensive process that

pulls staff away from core safety assessment activities.

Typically there is a tough timeline to abide by in terms of regulatory compliance. Once the

decision has been taken that an SAE (serious adverse event) qualifies for expedited reporting to

investigators and IRBs /IECs, little time is left. Within this limited time, sponsors must identify all

the investigators who need to receive the safety report, generate a cover letter and send the

report out to all recipients. Investigators typically are asked to sign off on the safety report as

proof they have read it.

To a large extent, this process can be automated by an investigator portal. Portals can generate a

list of recipients based on study and product information, generate template-based cover letters

and distribute the safety reports via web portal, e-mail or fax, according to each investigator’s

preferences. Through the portal, investigators have easy access to their safety reports, which

become part of the online investigator file. Read acknowledgements are tracked automatically,

reducing the administrative burden from investigators and CRAs and allowing the sponsor to

implement and benefit from a real-time process control. The documentation to be added to the

trial master file can be generated and, in case of an audit or inspection, all information is easily

available.

Portals can generate a list of recipients based

on study and product information, generate

template-based cover letters and distribute the

safety reports via web portal, e-mail or fax,

according to each investigator’s preferences.


4. Training Management

GCP requires investigators and other site personnel to be trained on general GCP aspects as well

as on study-specific procedures. As a result, trainings have to be defined and the corresponding

training material needs to be created. Staff are assigned to the trainings based on the roles they

have in the context of a study. Some of these trainings may be given face to face, such as during

investigator meetings. However, this may not be efficient for all trainings required and may not

work for new investigators joining a study already underway.

In these cases, making the training materials available online is a good option. Study personnel can

access the trainings through the investigator portal in the My Trainings section and confirm that the

training was taken and the content was understood. Sponsor users have full control over the

progress of the training and a central area to track the trainings taken. Upon successful completion

of training, certificates can be issued and added to the trial documentation automatically.

Sponsors have full control over the progress of

the training and a central area to track the

trainings taken.



Figures 3 and 4 – Safety Report Distribution: An investigator portal should provide templates and enable Sponsors to

easily prepare and distribute safety reports, cover letters and review recipient lists.

Figure 5 – Site Personnel Management. An investigator portal should assist in maintaining site personnel

records, including tracking of training.

5. Investigator Self-Registration

A good investigator network is a key asset of each clinical operations organization with finding new

potential investigators a vital supporting activity. An investigator portal can enable investigator self-

registration and help sponsors maintain an active pool of investigators for ongoing and future

studies.

Since key information about the study protocol needs to be published at registries such as

clinicaltrials.gov, sponsors can make this information available for selected studies on their webpage.

Upon visiting a sponsor’s web site, interested investigators can review the study outlines and express

their interest in participating via a self-registration process. This will bring sponsors into contact with

investigators they otherwise would have found difficult to identify. Sponsors can add the investigator

details to their investigator database and start to assess them, using site feasibility questionnaires or

conducting a pre-study site visit before they make a decision whether to include them into a specific

trial.

While this white paper has covered the key areas for which an investigator portal can streamline

and improve communications and collaboration between a sponsor and site staff, there are other

technology and design aspects you should be aware of as you undertake an evaluation of a

possible solution.

Upon visiting a sponsor’s web site, interested

investigators can review the study outlines and

express their interest in participating via a self-

registration process.


Stay Focused: Less Is More

Sometimes providers of software solutions, including investigator portals, are proud of what their

system can do. And in portals there are so many things one potentially could add. This “add-on

potential” is actually a risk to your success of implementing the investigator portal as your site

personnel needs to get trained on all the portal’s functionality and how to actually use all of its

many fantastic features.

It is worth remembering that an investigator portal is to be used by investigators. Anything that

does not support the interaction between sponsor or CRO and investigator should be kept

elsewhere. ArisGlobal recommends that you reconsider this “bells and whistles” portal approach in

favor of providing site staff with the necessary communication and collaboration you need with

them.

In real life, beyond participating in a sponsor’s study, doctors have other important things to do as

they focus on treating patients. Site personnel appreciate if the tools they are asked to use focus

on the really important tasks asked of them. Adding too much functionality only makes things

complex, tedious to train and harder to learn and remember.

Bottom line: when planning for an investigator portal, a tough evaluation that distinguishes

between critical features supporting key business processes and those that are just “nice to have”

will serve the best interests of both sponsors and investigators.

Single Sign-On

Investigators participating in multiple clinical trials complain about having to remember too many

passwords. In fact, many investigators have dozens of different passwords they need to use for

clinical trials they are participating in.

Even a single trial uses different tools such as EDC, IWRS, endpoint adjudication tools, tools

provided by any kind of central reading, etc., each requiring a different login account with a

different password. All of these need to be changed on a regular basis according to system

password policies.

For many investigators, many of whom obviously cannot remember all login details, the “solution”

is to store a long list of all passwords in their smartphones. Clearly this is not only a source of

annoyance to the investigators but also a serious risk from a security and GCP perspective.

Investigator portals can help to reduce the variety of passwords. As the name already says, portals

serve as a single entrance to all applications. Standards like SAML (security assertion markup

language), which is the open standard data format for exchanging authentication and authorization

between systems, helps to achieve single sign-on access even with applications from different

vendors and in-house applications.

It is worth remembering that an investigator

portal is to be used by investigators.

IMPORTANT TECHNOLOGY AND DESIGN ASPECTS



Figure 6 – SS0 Technology. Today’s modern technology, such as single sign-on, eliminates the problem of

remembering multiple usernames and passwords to access all clinical systems.

Security and Confidentiality

For a number of different stakeholders, security is a very important aspect when considering an

investigator portal. Business-critical information such as study protocols or safety reports is shared

over the internet. Sponsors clearly need to be confident only persons who should see this

information have access to it. Regulatory agencies are concerned about reliability and integrity of

the data, which cannot be guaranteed if the system does not meet basic security requirements.

Individuals such as investigators want to be sure their privacy is protected when they share

personal or financial information provided in CVs, contracts or other documents.

Many technical features are available these days, which can be considered as standard, such as data

encryption, digital signatures, configurable password policies, secure user identification, audit trails

or role-based access controls. However, security does not need to be taken care of only from a

technical perspective. Process controls also need to be in place to ensure sensitive data is not

shared in error. For example, in general, only approved versions of documents should be sent out

to investigational sites. Since a broad spectrum of data with different grades of criticality and

sensitivity is shared throughout a clinical trial, investigator portals need to support a variety of

process controls that can easily be adapted to specific business needs.

Intuitive Investigator-Driven Design

The intuitive design of any investigator portal can’t be over emphasized when the goal is to build

and improve investigator relations and acceptance of new technology. The best investigator portal

is useless if site people are not using it. Given the broad acceptance of EDC these days there can

be no doubt that most sites have the technical infrastructure and the willingness to use web-based

tools. However, it takes more to transform general willingness to active participation. Essentially,

investigators need to find the information they need fast.

Since a broad spectrum of data with different

grades of criticality and sensitivity is shared

throughout a clinical trial, investigator portals

need to support a variety of process controls

that can easily be adapted to specific business

needs.


There are two implications on this. First, the investigator portal must add value to the site

personnel and give them those pieces of information that are important for their daily work with

the trial. That’s where a well-designed, intuitive portal can make all the difference. Portals designed

from a sponsor perspective may not work properly. In addition, site users need to find the portal

easy to use. It is not good to think “we will train the investigators on this during the training

session or the investigator meeting.” Of course, training must be done and documented as GCP

requires it and, hence, every QA department wants to see it. But in reality people tend to forget.

So the second implication to be aware of is that training is no substitute for ease of use.

Perhaps a good test is to ask, “Can my boss use the site portal from an investigator perspective

without any training?” If the answer is “no,” the portal might be too complex. There is no reason

why an investigator portal should be more difficult to use than an e-mail inbox. And do not forget

to inform your investigators if there is important new information waiting for them in the portal.

They will not check the portal every morning first thing.

User-Friendly Dashboards Provide Cross-study Information at a Glance

One of the drawbacks we see in many EDC implementations is that EDC is set up (and sold) on a

study-by-study basis. As a result, cross-study information often is difficult to get both for sponsor

and site users. Investigator portals must be set up in a different way. Many pieces of information

cannot be attributed to a single study as, for example, investigator CVs, GCP training certificates

and SUSAR reports may apply to multiple studies. Feasibility questionnaires are sent out before

the decision is taken that a specific investigator participates in the study. While clinical trial portals

have a focus on study-related activities, they must be designed and allow to work across studies.

Immediately after login investigators, want to see condensed, high-level information guiding them

to what they need to do and what to pay attention to. Examples include:

• SUSARs

• Trainings to be completed

• New documents they need to read

• Enrollment plans

• Payments

• Serious Adverse Events

• EDC queries

• IMP information

• Contact details, e.g., of the safety officer or the responsible CRA

• Milestones

• Feasibility questionnaires

Perhaps a good test is to ask, “Can my boss

use the site portal from an investigator

perspective without any training?” If the answer

is “no,” the portal might be too complex.



This information typically resides buried in different applications like EDC, CTMS, IWRS or the trial

portal itself. However, investigators don’t have the time to drill down into different systems to

search for this information. Good portals offer the capability to surface and show it to the site

personnel in configurable, role-based dashboards.


Figure 7 – Configurable User Dashboards: Investigator portals should provide a user dashboard that is configurable

based on role, providing an at-a-glance overview of what information needs attention.

Clinical research depends on the timely collection and analysis of the myriad data that is collected

during the various stages of a clinical trial. Making decisions based on incomplete and inaccurate

information is not in the best interest of the sponsor or, ultimately, the patient.

Given the increased complexity of clinical trials, clinical operation departments are under increasing

pressure to raise efficiencies and streamline the processes, as well enhance decision making

through improved two-way communication and knowledge sharing.

As EDC reaches almost full adoption, sponsors now recognize that investigator portals represent

an important step forward in improving site relationships, reducing site initiation start-up times and

also reducing the high cost of site management.

The most important areas to focus on include investigator files, site feasibilities, training

management, investigator self-registration and safety reporting. Standards-based single sign-on takes

care of one of the most-heard of complaints by investigators. Well-designed, easy-to-use

investigator portals that provide secure communication and collaboration help sponsors and CROs

to take the next quantum leap in achieving electronic clinical operations.

REFERENCES[1] EPGCP Update Paper: Guidelines for retention of clinical trial records at investigator study sites.

Visit: http://gcprma.files.wordpress.com/2011/07/retention-at-inv-sites.pdf (accessed 16 October

2013)

[2] DIA Trial Master File (TMF) Reference Model. Visit: http://www.diahome.org/en-US/News-and-

Publications/Publications-and-Research/EDM-Corner.aspx (accessed 16 October 2013)

SUMMARY



ArisGlobal (www.arisglobal.com) is a leading provider of integrated software solutions for

pharmacovigilance and safety, regulatory affairs, clinical research and medical information and

compliance. Specific to clinical research, Total Clinical™, our integrated eClinical portal, improves

the execution of clinical programs by focusing on “smart integration” across core systems in clinical

operations, clinical data management and clinical safety.. This integrated portal provides access to

the solutions offered by ArisGlobal as well as to third-party systems from other technology

providers.

While each solution can be deployed independently, when deployed together, Total Clinical offers

a comprehensive and integrated platform for clinical research and safety.

eClinical Portal

• agWorld is an integrated eClinical platform providing single sign-on access to all eClinical

solutions, including third-party vendor applications. Consolidated metrics, milestones and KPIs

from all systems are delivered directly to a user’s dashboard.

Clinical Operations

• agClinical™ is a versatile CTMS that enables Sponsors and CROs to plan, track and control

all tasks related to clinical trials management.

• agDisclosure™ is an advanced solution that efficiently manages clinical trial registration and

reporting of results to clinicaltrials.gov, EudraCT and other registries.

• agSIR™ is an advanced reporting system that automates the distribution and tracking of clinical

safety reports to investigators.

• agCenter™ is the clinical research investigator site portal that significantly improves

investigator satisfaction and enables sponsors to reduce the time and cost of clinical trial

administrative management.

Clinical Data Management

• agCapture™ is a cost-effective, comprehensive EDC system to capture, clean and report

clinical trial data.

• agOutcomes™ is an advanced electronic patient reported outcome (ePRO) system that can

run standalone or fully integrated with a traditional EDC study.

• agSupply™ is an integrated IWRS, randomization and supply management system that

manages the entire clinical supply life cycle.

• agEncoder™ is a centralized dictionary coding tool that enables fast and consistent coding of

medical terms.

For more information on ArisGlobal solutions for clinical research,

visit www.totalclinical.com.

ABOUT ARISGLOBAL


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